Implantable device with ultrasound probe, navigation, and patient monitoring

Abstract

An example navigation system for a procedure at a target location within a region of interest includes a device configured to be removably implanted at a location within the region. The implant location has a known position relative to the target location. The implantable device includes an anchor configured to secure the implantable device to a structure at the implant location and one of an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field or an EM emitter configured to generate the EM field. The system also includes an instrument including an additional EM tracker configured to detect the position-dependent property. The system additionally includes a processing unit configured to determine a relative position between the instrument and the implantable device based on the detected position-dependent property and output an indication of the relative position between the instrument and the implantable device.

Description

Attorney Docket No. A0012175W001IMPLANTABLE DEVICE WITH ULTRASOUND PROBE, NAVIGATION, AND PATIENT MONITORINGCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 692,802, filed September 10, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present technology is generally related to an implantable device capable of providing imaging and / or information related to a medical procedure.BACKGROUND

[0003] Ultrasonography is used for imaging in a variety of fields, including medical imaging. An ultrasound (US) transducer emits US waves which are reflected by echogenic or echoic materials (for example bone or materials with physical properties similar to bone) and absorbed or allowed to pass through by non-echogenic or anechoic materials (for example purified water or materials with physical properties similar to purified water). The echo or reflection from echoic materials as opposed to the absorption or non-reflection of anechoic materials is used to determine imaging data, which is provided to a user such as a surgeon or US technician via a user interface.SUMMARY

[0004] The techniques of this disclosure generally relate to provide an implantable device capable of aiding in navigation of an instrument (e.g., a transcatheter instrument, etc.) to and within a region of interest (e.g., a region of interest of an intracardiac transcatheter procedure, etc.) and / or monitoring of the region of interest (e.g., monitoring intracardiac pressure, monitoring a cardiac cycle, providing temporary cardiac pacing, etc.). Various examples provide navigation assistance via electromagnetic tracking of the implantable device and one or more instruments and / or via ultrasound imaging data obtained from the implantable device.Attorney Docket No. A0012175W001

[0005] In one aspect, the present disclosure provides a navigation system for a procedure associated with a target location within a region of interest. The navigation system includes an implantable device configured to be removably implanted at an implant location within the region of interest. The implant location has a known position relative to the target location. The implantable device includes an anchor configured to secure the implantable device to a structure at the implant location and one of an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field or an EM emitter configured to generate the EM field. The navigation system also includes an instrument including an additional EM tracker configured to detect the position-dependent property of the EM field. The navigation system further includes a processing unit configured to determine a relative position between the instrument and the implantable device based on the detected position-dependent property of the EM field and output an indication of the relative position between the instrument and the implantable device.

[0006] In another aspect, the disclosure provides a navigation system for a procedure associated with a target location within a region of interest. The navigation system includes an instrument. The navigation system also includes an implantable device configured to be removably implanted at an implant location within the region of interest. The implant location has a known position relative to the target location. The implantable device includes an anchor configured to secure the implantable device to a structure at the implant location and an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest. The portion of the region of interest includes the target location. The navigation system additionally includes a processing unit configured to receive the US imaging data and output an US image based on the US imaging data.

[0007] In other aspects, the disclosure provides a device configured to be implanted within a region of interest. The device includes an anchor configured to removably secure the device to a structure within the region of interest at a location within the region of interest. The device also includes an electromagnetic (EM) emitter configured to generate an EM field with a position-dependent property across the region of interest. The device additionally includes a transmitter configured to transmit data. The device further includes an internal power source configured to provide power to the device.Attorney Docket No. A0012175W001

[0008] In further aspects, the disclosure provides a device configured to be implanted within a region of interest. The device includes an anchor configured to removably secure the device to a structure within the region of interest at a location within the region of interest. The device also includes an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field. The device additionally includes a transmitter configured to transmit data. The data indicates the detected position-dependent property of the EM field. The device further includes an internal power source configured to provide power to the device.

[0009] In additional aspects, the disclosure provides a method of providing navigation assistance data in connection with a procedure at a target location within a region of interest. The method includes securing a device to a structure at an implant location in the region of interest. The method also includes receiving the navigation assistance data via at least one of a first signal from the device or a second signal received from an instrument. The method additionally includes determining a relative position between the device and the instrument based on the navigation assistance data. The method further includes navigating the instrument to the target location based at least in part on the determined relative position. Additionally, the method includes performing the procedure at the target location and removing the device from the structure.

[0010] Additional aspects of the disclosure provide a navigation system for an intracardiac transcatheter procedure associated with a heart valve within a region of interest. The navigation system includes an implantable device configured to be removably implanted at an implant location within the region of interest. The implant location has a known position relative to the heart valve. The implantable device includes an anchor configured to secure the implantable device to an anatomical structure at the implant location and one of an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field or an EM emitter configured to generate the EM field. The navigation system also includes a transcatheter instrument including an additional EM tracker configured to detect the position-dependent property of the EM field. The navigation system additionally includes a processing unit configured to determine a relative position between the transcatheter instrument and the implantable device based on the detected position-dependent property of the EM field and output anAttorney Docket No. A0012175W001 indication of the relative position between the transcatheter instrument and the implantable device.

[0011] Other aspects of the disclosure provide a navigation system for an intracardiac transcatheter associated with a heart valve within a region of interest. The navigation system includes an instrument. The navigation system also includes an implantable device configured to be removably implanted at an implant location within the region of interest. The implant location has a known position relative to the heart valve. The implantable device includes an anchor configured to secure the implantable device to an anatomical structure at the implant location and an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest. The portion of the region of interest comprises the heart valve. The navigation system additionally includes a processing unit configured to receive the US imaging data and output an US image based on the US imaging data.

[0012] In still further aspects, the disclosure provides a device configured to be implanted within a region of interest of an intracardiac transcatheter procedure. The device includes an anchor configured to removably secure the device to an anatomical structure within the region of interest at a location within the region of interest. The device also includes an electromagnetic (EM) emitter configured to generate an EM field with a position-dependent property across the region of interest. The device additionally includes a transmitter configured to transmit data and an internal power source configured to provide power to the device.

[0013] Additionally, aspects of the disclosure provide a device configured to be implanted within a region of interest of an intracardiac transcatheter procedure. The device includes an anchor configured to removably secure the device to an anatomical structure within the region of interest at a location within the region of interest. The device also includes an electromagnetic (EM) tracker configured to detect a positiondependent property of an EM field. The device additionally includes a transmitter configured to transmit data. The data indicates the detected position-dependent property of the EM field. The device further includes an internal power source configured to provide power to the device.

[0014] Other aspects of the disclosure provide a method of providing navigation assistance data in connection with an intracardiac transcatheter procedure at a heart valveAttorney Docket No. A0012175W001 within a region of interest. The method includes securing a device to an anatomical structure at an implant location in the region of interest. The method also includes receiving the navigation assistance data via at least one of a first signal from the device or a second signal received from a transcatheter instrument. The method additionally includes determining a relative position between the device and the transcatheter instrument based on the navigation assistance data. The method further includes navigating the transcatheter instrument to the heart valve based at least in part on the determined relative position. Additionally, the method includes performing the intracardiac transcatheter procedure at the heart valve and removing the device from the anatomical structure.

[0015] An additional aspect of the disclosure provides a device configured to be implanted within a region of interest. The device includes an anchor configured to removably secure the device to a structure within the region of interest at a location within the region of interest. The device also includes an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest. The device additionally includes a transmitter configured to transmit data. The data includes the US imaging data. The device further includes an internal power source configured to provide power to the device.

[0016] A further aspect of the disclosure provides a device configured to be implanted within a region of interest of an intracardiac transcatheter procedure. The device includes an anchor configured to removably secure the device to an anatomical structure within the region of interest at a location within the region of interest. The device also includes an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest. The device additionally includes a transmitter configured to transmit data. The data includes the US imaging data. The device further includes an internal power source configured to provide power to the device.

[0017] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.Attorney Docket No. A0012175W001BRIEF DESCRIPTION OF DRAWINGS

[0018] FIG. 1 is a schematic perspective view of one example of a treatment system useable in connection with various examples discussed herein.

[0019] FIG. 2 is a schematic block diagram illustrating an example system of hardware components capable of implementing examples disclosed herein.

[0020] FIG. 3 is a block diagram of an example implantable device capable of providing navigation assistance data in connection with a procedure.

[0021] FIGS. 4A and 4B show images of an external view and an internal view of an example implantable device capable of providing navigation assistance data in connection with a procedure.

[0022] FIGS. 5A and 5B show images of an example implanted device including an electromagnetic (EM) tracker and secured at an implant location at or near a right ventricular apex, such as for a transcatheter tricuspid valve replacement (TTVR) procedure.

[0023] FIGS. 6A and 6B show images of an example implanted device including an EM emitter and secured at an implant location at or near a right ventricular apex, such as for a TTVR procedure.

[0024] FIGS. 7A and 7B show images of an example implanted device including an ultrasound (US) probe and secured at an implant location at or near a right ventricular apex, such as for a TTVR procedure.

[0025] FIG. 8 shows an image of an example implanted device secured at an implant location at or near the lower end of the superior vena cava (SVC), such as for a TTVR procedure.

[0026] FIG. 9 is a flowchart of an example method of providing navigation assistance data in connection with a procedure at a target location within a region of interest.DETAILED DESCRIPTION

[0027] Various examples provide an implantable device capable of aiding in navigation of an instrument (e.g., a transcatheter instrument, etc.) to and within a region of interest (e.g., a region of interest of an intracardiac transcatheter procedure, etc.) and / or monitoring of the region of interest (e.g., monitoring intracardiac pressure, monitoring a cardiac cycle, providing temporary cardiac pacing, etc.). Various examples provideAttorney Docket No. A0012175W001 location data associated with the implantable device and / or the instrument (e.g., such as via an electromagnetic tracking system, etc.) to facilitate navigation of the instrument. Additionally or alternatively, examples provide ultrasound (US) data obtained via an US probe within the implantable device to facilitate navigation of the instrument.

[0028] Current clinical methods of imaging the intracardiac space using TEE have demonstrated feasibility in connection with transfemoral mitral valve replacement, and these methods are also useable in tricuspid valve replacement. However, clinical experience has identified challenges with conventional TEE imaging, which can require significant and constant monitoring by multiple physicians and skilled specialists in every implant procedure, especially in tricuspid imaging, such as for a transcatheter tricuspid valve replacement (TTVR) procedure.

[0029] In general, these issues add significant cognitive burden and stress during the procedure because of the high level of vigilance required to avoid contact between the delivery system and anatomical features. Patient outcomes are highly dependent on the vigilance of multiple specialists and effective communication between them to interpret the frequently suboptimal images acquired using TEE. Current transcatheter tricuspid valve replacement (TTVR) procedures have multiple nuances in connection with imaging the native anatomy while deploying the implant. These nuances include shadowing, TEE positioning, and a limited field of view.

[0030] In contrast to conventional techniques, various examples include an implantable device able to be attached to a structure (e.g., prior to a procedure and / or a pre-procedure monitoring period, etc.), used during the procedure to assist in navigation of one or more instruments, and removed from the structure (e.g., after the procedure and / or a post-procedure monitoring period, etc.). Examples assist in navigation via one or more techniques, such as providing information regarding the relative positions (e.g., which can include position of multiple tracked datums, from which orientation, etc. is able to be determined, etc.) of an instrument and the implanted device through an electromagnetic tracking system. Additionally or alternatively, examples assist in navigation by obtaining US imaging from the position of the implanted device, providing imaging of an entire valve or other target location, free from shadowing. The implanted device is able to wirelessly transmit data (e.g., for navigation assistance and / or patient monitoring, etc.) for use by a workstation, etc. used before, during, and / or after the procedure. In variousAttorney Docket No. A0012175W001 examples, navigation assistance data (e.g., relative position data, US imaging data, etc.) and / or patient monitoring data (e.g., intracardiac pressure, etc.) from the implanted device and / or instrument is incorporated with other data (e.g., pre-procedural or intra-procedural imaging, etc.) for output (e.g., visually via a display, auditorily, etc.) to a user. In some such examples, the navigation assistance data and / or patient monitoring data is included in a 3D model of the region of interest constructed based on the other data, the navigation assistance data, and / or the patient monitoring data.

[0031] Various examples are employable in connection with a range of procedures. One example use case is a clinical procedure for a cardiac valve replacement such as TTVR or transcatheter mitral valve replacement (TMVR), but examples are also employable in connection with a range of other scenarios, including other intracardiac transcatheter procedures such as transcatheter edge-to-edge repair (TEER), annuloplasty, left atrial appendage occlusion (LAAO), etc.

[0032] The implant location where the implanted device is removably attached to the structure (e.g., anatomical structure, etc.) varies between examples and / or use cases (e.g., associated procedure(s), etc.). For a TTVR procedure, example implant locations include the right ventricular wall / apex and / or within vascular near the tricuspid valve (TV), such as the lower portion of the superior vena cava. For a TMVR procedure, example implant locations include the left ventricular wall / apex or the left atrial wall. In various examples, an implant location within vasculature such that there is an unobstructed direct path to or view (e.g., via US, etc.) of a target location (e.g., heart valve, etc.) from an implanted device at the implanted location is “near” the target location (e.g., heart valve, etc.).

[0033] Referring to FIG. 1, illustrated is a schematic perspective view of one example of a treatment system 10 useable in connection with various examples. Treatment system 10 includes a computing device 100, a display 110, a table 120, one or more electromagnetic (EM) field emitters (e.g., transmitter(s), etc.) 121, an instrument 130 (e.g., a transcatheter device, etc.), an ultrasound (US) imager 140 that includes one or more US probes (e.g., a US probe of an implantable device as discussed herein, a transesophageal echocardiogram (TEE) probe, a transthoracic echocardiogram (TTE) probe, and / or an intracardiac echocardiogram (ICE) probe, etc.), a US workstation 150, and an implanted device that includes one or more of an EM field emitter 121, a US probe of US imager 140, or one or more EM trackers as discussed herein. In various examples, computingAttorney Docket No. A0012175W001 device 100 is, for example, a laptop computer, desktop computer, tablet computer, smart phone, or other similar device. In examples, computing device 100 is configured to control an electrosurgical generator, a peristaltic pump, a power supply, and / or any other accessories and peripheral devices relating to, or forming part of, system 10. Display 110 is configured to output a two-dimensional (2D) ultrasound (US) image, which in various examples is output along with additional information (e.g., saved views, feedback regarding alignment of the US probe with a saved view, US imaging parameters, etc.). In various examples, table 120 is, for example, an operating table or other table suitable for use during a surgical procedure.

[0034] The EM field emitter(s) 121 generate an EM field with a position-dependent property (e.g., a three-dimensional (3D) magnetic field generated over a patient and / or a region of interest for a procedure, etc.) during the procedure and form part of an EM tracking system. The EM tracking system facilitates tracking the position and orientation of US probe(s) (e.g., a US probe of an implantable device, a TEE probe, etc.) of the US imager 140 within a region of interest (e.g., an anatomical region associated with a procedure within the body of a patient, such as a heart or portion thereof, etc.) and / or the position and orientation of one or more instruments 130 (e.g., a transcatheter delivery device, an implantable device, etc.). In various examples, the EM field emitter(s) 121 include various components, such as a specially designed pad to be placed under, or integrated into, an operating table or patient bed (e.g., the table 120, etc.), an EM field emitter 121 mounted on the table 120 (e.g., via an adjustable arm) and configured to be placed adjacent to a patient (e.g., adjacent to a patient’s head, etc.). Additionally, in the same or other examples, the EM field emitter(s) 121 include an EM field emitter 121 included within an implantable device.

[0035] The EM tracking system of the system 10 includes the EM field emitter(s) 121 and also includes one or more tracked devices (e.g., instrument(s) 130, US probe(s) of the US imager 140, etc.), wherein the tracked device(s) include EM tracker(s) such as EM sensor array(s) (e.g., EM coils, etc.) that are configured to detect the position-dependent property of the EM field (e.g., a magnitude and / or a direction associated with the EM field, such as via interaction of the EM field with EM coils, etc.), from which the position of the EM tracker is able to be determined. In some examples determining the position of an instrument 130, an implanted device, etc. includes determining the orientation of theAttorney Docket No. A0012175W001 instrument 130, the implanted device, etc. (e.g., via determining a direction associated with the EM field, determining two or more positions on the instrument 130, the implanted device, etc.). The EM field(s) generated by the EM field emitter(s) 121 are detected by the EM tracker(s) of the tracked device(s), and the EM field by each tracked device is communicated to the computing device 100 (e.g., via wired and / or wireless connection(s)) and / or to the US workstation 150. In various examples, tracked device(s) include therapeutic device(s) (e.g., replacement valve, etc.), therapy delivery system(s) (e.g., transcatheter delivery system, etc.) and / or implantable device(s) (e.g., an implantable device as discussed herein, e.g., a device including one or more of an US probe, an EM field emitter, sensor(s), electrodes for temporary cardiac pacing, etc.).

[0036] In various examples, the computing device 100 and / or the US workstation compares the signal(s) sent by the EM field emitter(s) with the signal(s) received by the tracked device(s) to interpret the position(s) of the tracked device(s) in 3D space relative to the region of interest.

[0037] While the present disclosure describes the use of system 10 in a surgical environment, it is also envisioned that some or all of the components of system 10 may be used in alternative settings, for example, an imaging laboratory and / or an office setting. Additionally, while various examples are discussed in connection with a region of interest that is a cardiac region or a portion of a cardiac region of a patient, examples are also employable in alternative settings, such as any of a variety of regions of interest (e.g., noncardiac anatomical regions of interest, non-anatomical regions of interest, etc.) that include structure(s) suitable for implanting an implantable device as discussed herein, etc.

[0038] In addition to the EM tracking system, the instrument 130 may also be visualized by using ultrasound imaging. US imager 140, which includes the US probe, is useable to image the patient's body during the procedure to visualize the position of the surgical instruments, such as instrument 130, inside the patient's body. In various examples, the US imager 140 has an EM tracking sensor embedded within or attached to the US probe, for example, a clip-on sensor, or a sticker sensor. The position / orientation of the tracked device(s) as determined by the EM tracking system, in combination with the US image data obtained by the US imager(s) 140, allows for the ability to incorporate the position(s) / orientation(s) of tracked device(s) and the US image data within a 3D model of a region of interest based on the US image data. The position / orientation of the instrumentAttorney Docket No. A0012175W001130 determined by the EM tracking system and / or by the US imager are useable to register the position / orientation of the instrument 130 to the 3D model for tracking. In various examples, an implantable device (e.g., including one or more of a US sensor, an EM field emitter, an EM sensor, and / or one or more patient monitoring sensors) is positioned in or near a region of interest, such as placed inside the body of the patient (e.g., an implantable device implanted within or near the region of interest, etc.). The EM tracking system tracks the position of US sensor(s) 140 and the instrument 130 inside the body of the patient.

[0039] In various examples, the position of the instrument 130 within the body of the patient is able to be tracked during the surgical procedure. One example method of tracking the position of the instrument 130 includes using the EM tracking system, which tracks the position of the instrument by tracking sensors attached to or incorporated in the instrument that sense a position-dependent EM field. Various types of sensors are useable, such as a printed sensor, the construction and use of which is more fully described in U.S. Patent Publication No. 2016 / 0174873, entitled MEDICAL INSTRUMENT WITH SENSOR FOR USE IN A SYSTEM AND METHOD FOR ELECTROMAGNETIC NAVIGATION, the entirety of which is incorporated by reference herein. Prior to starting the procedure, the clinician can verify the accuracy of the tracking system and / or US imager 140 using any suitable technique or techniques, for example, as described in U.S. Patent 8,811,662, entitled METHOD AND APPARATUS FOR CALIBRATING AND REALIGNING AN ULTRASOUND IMAGE PLANE TO A NAVIGATION TRACKER, the entirety of which is incorporated by reference herein.

[0040] For ease of illustration, specific examples are discussed in connection with a transcatheter device as the instrument 130, in connection with a TTVR and / or TMVR procedure. However, in various examples, any suitable instrument or device 130 can be utilized with the system 10, e.g., one or more implantable devices, implant delivery devices, therapy delivery devices, surgical devices, mechanical circulatory support (e.g. LVAD) devices, coronary stent devices, heart valve devices, heart valve repair devices, cardiac ablation devices, cardiac lead devices, drug delivery devices, catheter delivery devices, and endoscopic delivery devices.

[0041] FIG. 2 is a schematic block diagram illustrating an example system 200 of hardware components capable of implementing computing devices (e.g., the computingAttorney Docket No. A0012175W001 device 100, etc.) included in or employed in connection with various examples of the systems and methods disclosed herein. The system 200 can include various systems and subsystems, and in some examples is employable as the computing device 100. The system 200 can be a personal computer, a laptop computer, a workstation, a computer system, an appliance, an application-specific integrated circuit (ASIC), a server, a server BladeCenter, a server farm, etc.

[0042] The system 200 can include a system bus 202, a processing unit 204, a system memory 206, memory devices 208 and 210, a communication interface 212 (e.g., a network interface), a communication link 214, a display 216 (e.g., a video screen), and an input device 218 (e.g., a keyboard, touch screen, and / or a mouse). The system bus 202 can be in communication with the processing unit 204 and the system memory 206. The additional memory devices 208 and 210, such as a hard disk drive, server, standalone database, or other non-volatile memory, can also be in communication with the system bus 202. The system bus 202 interconnects the processing unit 204, the memory devices 206- 210, the communication interface 212, the display 216, and the input device 218. In some examples, the system bus 202 also interconnects an additional port (not shown), such as a universal serial bus (USB) port.

[0043] The processing unit 204 can be a computing device and can include an application-specific integrated circuit (ASIC) and / or include one or more processing cores (e.g., single-core, multi-core), which in various examples include CPU(s), GPU(s), etc. The processing unit 204 executes a set of instructions to implement the operations of examples disclosed herein. The processing unit can include a processing core.

[0044] The additional memory devices 206, 208, and 210 can store data, programs, instructions, database queries in text or compiled form, and any other information that may be needed to operate a computer. The memories 206, 208 and 210 can be implemented as computer-readable media (integrated or removable), such as a memory card, disk drive, compact disk (CD), or server accessible over a network. In certain examples, the memories 206, 208 and 210 can comprise text, images, video, and / or audio, portions of which can be available in formats comprehensible to human beings. Additionally or alternatively, the system 200 can access an external data source or query source through the communication interface 212, which can communicate with the system bus 202 and the communication link 214.Attorney Docket No. A0012175W001

[0045] In operation, the system 200 can be used to implement one or more parts of a system in accordance with examples discussed herein. Computer executable logic for implementing a system (e.g., the system 10, etc.) that employs navigation assistance data and / or patient monitoring data from an implantable device resides on one or more of the system memory 206, and the memory devices 208 and 210 in accordance with certain examples. The processing unit 204 executes one or more computer executable instructions originating from the system memory 206 and the memory devices 208 and 210. The terms “computer readable medium” or “machine readable medium” as used herein includes a medium that participates in providing instructions to the processing unit 204 for execution and in various examples includes non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules, or other data. For example, computer-readable storage media includes RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, Blu-Ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the desired information and that can be accessed by computing device 100. In one or more embodiments, computer-readable storage media can be stored in the cloud or remote storage and accessed using any suitable technique or techniques through at least one of a wired or wireless connection.

[0046] In various examples, one or more software programs stored in at least one of the system memory 206, the memory device 208, or the memory device 210 include instructions that are executed by the processing unit 204 to perform operations associated with the examples.

[0047] In one example, imaging data accessed by the system 200 is used in selecting an implant location for an implantable device as described herein, for guiding a delivery system of the implantable device to the implant location to implant the device, and / or for guiding an instrument to the implant location to remove the implanted device from the implant location (e.g., via engaging with a tether on the implanted device, etc.). In the same or other examples, the system 200 provides instructions (e.g., based on user inputs, etc.) to steer a delivery system for implant and / or removal of an implantable device as discussed herein. Similarly, in various examples, the system 200 provides instructionsAttorney Docket No. A0012175W001(e.g., based on user inputs, etc.) to steer an instrument in connection with a procedure performed while an implantable device is implanted (e.g., and providing navigation assistance data, generating an EM field for navigation assistance, and / or providing sensor data, etc.).

[0048] In various examples, the system 200 receives navigation assistance data (e.g., EM tracking data from an instrument based on an EM field emitted by an implanted device and / or one or more other EM emitters, EM tracking data and / or US imaging data from an implanted device, etc.) and / or patient monitoring data (e.g., from sensor(s) of an implanted device, etc.), and generates outputs (e.g., via a display, etc.) to a user that characterize the navigation assistance data and / or patient monitoring data. Because of the implant location of the implanted device, the navigation assistance data (e.g., EM tracking data, US imaging data, etc.) of various examples provides accurate data for navigating an instrument (e.g., the instrument 130, etc.) to a target location (e.g., heart valve, etc.) without the shadowing, field of view limitations, and US probe (e.g., TEE probe, etc.) positioning problems of conventional navigation techniques used in various procedures.

[0049] Additionally, in various examples, the system 200 transmits instructions, parameters for patient monitoring data and / or temporary cardiac pacing, etc. to the implantable device via a wireless connection (e.g., prior to implantation or while implanted, etc.) or a wired connection (e.g., prior to implantation, etc.). In some examples, parameters for patient monitoring data include thresholds for generation of alerts (e.g., alerts during pre-procedural and / or post-procedural monitoring, alerts during a procedure, etc.). Example parameters for generation of alerts include a first pressure threshold for generating an alert when a pressure at the implanted device (e.g., an intracardiac pressure, etc.) is greater than the first threshold, a second first pressure threshold for generating an alert when a pressure at the implanted device (e.g., an intracardiac pressure, etc.) is below the second threshold, etc. Additionally, parameters are able to be set for cardiac signal monitoring (e.g., solely for monitoring, in connection with temporary cardiac pacing, etc.), such as alerts related to conduction disturbances and / or undersensing.

[0050] Referring to FIG. 3, illustrated is a block diagram of an example implantable device 300 capable of providing navigation assistance data in connection with a procedure. In various examples, the implantable device 300 includes one or more of the optionalAttorney Docket No. A0012175W001 components shown in FIG. 3. For example, the implantable device 300 includes one or more of an EM emitter configured to generate a position-dependent EM field, an EM tracker configured to detect the position-dependent EM field, or a US probe configured to generate US imaging data (e.g., via a US transducer, such as a phased array for generating multiplanar US imaging data, etc.). Additionally, some examples include one or more sensors, etc. 340. In various examples, the sensor(s), etc. 340 include one or more of sensor(s) (e.g., pressure sensor(s), sensor(s) for monitoring a periodic electrical signal such as a cardiac signal, etc.) and / or electrical leads configured to generate a periodic electrical signal (e.g., for temporary cardiac pacing, etc,), etc. Examples of the implantable device 300 also include a transmitter and / or transceiver 350 configured to transmit navigation assistance data (e.g., from the EM tracker 320 and / or the US probe 330, etc.), sensor and / or patient monitoring data (e.g., from the sensor(s), etc. 340, etc.). Additionally, in various examples, a transceiver 350 is also configured to receive data, parameters, etc. (e.g., from a computing device 100 of FIG. 1, a system 200 of FIG. 2, etc.), such as parameters for generating alerts based on data obtained via the sensor(s), etc. 340, configuration of an EM emitter 310, an EM tracker 320, an US probe 330, sensors etc. 340, etc. Various examples include a control component 360 that controls one or more components of the implantable device 300 (e.g., the EM emitter 310, the EM tracker 320, the US probe 330, the sensor(s) etc. 340, the transmitter / transceiver 350, etc.) and / or outputs data to or receives data from the transmitter / transceiver 350, etc. The internal power source 370 (e.g., a battery, etc.) provides power to one or more components of the implantable device 300. The anchor 380 secures the implantable device to a structure (e.g., cardiac tissue and / or vasculature, etc.) at an implant location, and in various examples includes tines, an expandable stent (e.g., for implant locations within vasculature, etc.), etc. Various examples of the implantable device 300 also include a tether 390 configured to couple with an instrument for removal of the implantable device 300 from the implant location. In some examples (e.g., including an expandable stent as the anchor 380, etc.), the tether 390 is omitted and the implantable device 300 remains in contact with a delivery vehicle / instrument while at the implant location.

[0051] In various locations, the implant location is selected during a prescreening procedure. In connection with an example TTVR procedure, the implant location can be selected to be perpendicular along the axis of the tricuspid valve (e.g., a similar locationAttorney Docket No. A0012175W001 can be selected relative to the mitral valve for an example TMVR procedure, etc.), for example, such that the axis of the implanted device 300 provides a tracked position / orientation relative to the target location (e.g., tricuspid valve, etc.) for alignment of an instrument (e.g., the instrument 130, etc.), such as the axis of the implanted device 300 aligned parallel or nearly parallel (e.g., within ±5°, within ±10°, within ±15°, etc.) to a line from the target location to the implant location. In some examples, after implantation, the angle of the implanted device 300 relative to parallel is determined and used as additional information for navigation and alignment of an instrument. In various examples, deployment and / or removal of the implanted device 300 is facilitated using one or more imaging modalities (e.g., from US probes such as of US imager 140 of FIG. 1, computed tomography (CT) imaging, etc.), including data from one or more imaging modalities co-registered to and / or overlaid on each other.

[0052] Various examples provide patient monitoring capabilities (e.g., sensor data obtained via the sensor(s) etc. 340 transmitted by the transmitter / transceiver 360, etc.), such as intracardiac pressure sensing, cardiac signal monitoring, etc. Examples of the implantable device 300 are useable for patient monitoring pre-procedurally and / or to determine suitability, timing, etc. for the procedure. Various examples of the implantable device 300 are also useable for patient monitoring during the procedure, such as to ensure that the patient is stable, to generate alerts to a user, and / or for patient safety during therapy delivery with an instrument. Additionally or alternatively, some examples of the implantable device 300 are useable to provide temporary cardiac pacing to a patient (e.g., for some examples of the sensor(s) etc. 340, etc.) before, during, or after the procedure. In the same or other examples, the implantable device 300 facilitates patient monitoring postprocedure, such as to monitor patient recovery. In various examples providing patient monitoring and / or temporary cardiac pacing, the implantable device 300 transmits data wirelessly from the implant location via the transmitter / transceiver 360.

[0053] Data transmitted via transmitter / transceiver 360 from the implantable device 300 (e.g., navigation assistance data from an EM tracker 320, US imaging data from a US probe 330, patient monitoring data from sensor(s) etc. 340, etc.) is collected via an external wireless receiver (e.g., of the computing device 100 of FIG. 1, the communication interface 212 of FIG. 2, etc.) for processing in a console, workstation, etc. (e.g., the computing device 100 of FIG. 1, system 200 of FIG. 2, etc.).Attorney Docket No. A0012175W001

[0054] The implantable device 300 is temporarily secured to the implant location for a period of time that can vary significantly between examples. In some examples involving a relatively short period of time, the implantable device 300 is at the implant location primarily or solely for the procedure and remains in contact with a delivery system for the implantable device 300 (e.g., examples that include an expandable stent as the anchor 380, etc.) while at the implant location. Alternatively, in some examples, the implantable device 300 is secured at the implant location prior to the procedure (e.g., including for preprocedural patient monitoring, etc.) and remains at the implant location after the procedure for patient monitoring until a determination is made to end continued patient monitoring (e.g., the patient has sufficiently recovered, etc.), after which the implantable device 300 is recovered (e.g., via a tether 390, etc.) and removed from the implant location.

[0055] Referring to FIGS. 4A and 4B, illustrated are images showing an external view (in FIG. 4A) and an internal view (in FIG. 4B) of an example implantable device 400 (e.g., as one example of the implantable device 300, etc.) capable of providing navigation assistance data in connection with a procedure. The example implantable device 400 includes an EM tracker 420 (e.g., micro coils for EM tracking in 3D, etc.), a US probe 430 (e.g., a phased array configured to acquire multiplanar US imaging data, etc.), sensor(s) etc. 440 (e.g., an intracardiac pressure sensor and / or other patient monitoring capabilities, etc.), a transmitter / transceiver 460 (e.g., for wireless transmission of data to an external console / device such as computing device 100 of FIG. 1, etc.), an internal power supply 470 (e.g., an internal power source such as a battery, etc.), and an anchor 480 (e.g., a temporary and / or retrievable tissue anchoring mechanism such as the illustrated set of tines, etc.). The data transmitted by the transmitter / transceiver 460 includes one or more of 3D position data (e.g., determined from the EM tracker 420), US imaging data (e.g., determined from the US probe 430, patient monitoring data (e.g., determined from the sensor(s) etc. 440), etc. The example implantable device 400 is one example of an implantable device 300 of FIG. 3, in which the EM tracker 420 is an example of an EM tracker 320, the US probe 430 is an example of an US probe 330, the sensor(s) etc. 440 are an example of sensor(s) etc. 340, the transmitter / transceiver 460 is an example of a transmitter / transceiver 360, and the anchor 480 is an example of an anchor 380.

[0056] Referring to FIGS. 5A and 5B, illustrated are images showing an example implanted device 500 (e.g., as an example of the implantable device 300 of FIG. 3)Attorney Docket No. A0012175W001 including an EM tracker 520 (e.g., as an example of the EM tracker 320, etc.) and secured at an implant location at or near a right ventricular apex, such as for a TTVR procedure. TTVR is one example use case of various examples, which can improve the effectiveness of tricuspid replacement therapy by providing an alternate imaging modality from conventional imaging modalities, such as TEE, which has shadowing during the TTVR procedure.

[0057] FIGS. 5A and 5B show a use case of a TTVR procedure where examples provide navigation assistance data from an alternate imaging modality based on EM tracking. An implanted device 500 (e.g., as one example of implantable device 300 of FIG. 3, etc.) is temporarily secured to an anatomical structure (e.g., the interior of the heart, etc.) at an implant location (e.g., at or near the right ventricular apex, etc.). Both the implanted device 500 and a delivery system capsule 505 (e.g., an example of an instrument 130 of FIG. 1, etc.) include EM trackers 520. The EM trackers 520 of the implanted device 500 and the delivery system capsule 505 detect the position-dependent EM field generated by the EM emitter 510 (e.g., an external EM emitter not at the location shown in FIG. 5B, etc.) and, based on the detected position-dependent EM field, the locations (e.g., including orientations) of the implanted device 500 and the delivery system 505 are determined (e.g., by the computing device 100 of FIG. 1, system 200 of FIG. 2, etc.). The location of the implanted device 500 (as determined via the EM tracker 520 of the implanted device 500) is useable as an origin point to identify and aid in deployment accuracy of the prosthetic valve by determining and / or viewing the position of the delivery system capsule 505 (as determined via the EM tracker 520 of the delivery system capsule 505) relative to the implanted device 500. Various examples display visual aids to a user based on the relative positions of the implanted device 500 and the delivery system capsule 505. In various examples, a cone 525 is defined (e.g., coaxial with the axis of the implanted device 500 and / or with a line from the implanted device 500 to a center of the tricuspid valve) and / or displayed to a user to aid in aligning the delivery system capsule 505 coaxially with the implanted device 500 and / or tricuspid valve. Additionally, in various examples leaflet commissure points of the tricuspid valve (e.g., and / or a perpendicular distance of the leaflet commissure points from the tracked position of the implanted device 500, etc.) are identified and / or displayed to a user to aid in navigating theAttorney Docket No. A0012175W001 delivery system capsule 505 with respect to the native anatomy of the specific patient of the procedure.

[0058] Referring to FIGS. 6A and 6B, illustrated are images showing an example implanted device 600 (e.g., as an example of the implantable device 300 of FIG. 3) including an EM emitter 610 (e.g., as an example of the EM emitter 310, etc.) and secured at an implant location at or near a right ventricular apex, such as for a TTVR procedure. FIGS. 6A and 6B show another example that can improve the effectiveness of tricuspid replacement therapy by providing an alternate imaging modality from conventional imaging modalities, such as TEE, which has shadowing during the TTVR procedure.

[0059] FIGS. 6A and 6B show another use case of a TTVR procedure where examples provide navigation assistance data from an alternate imaging modality based on EM tracking. An implanted device 600 (e.g., as one example of implantable device 300 of FIG. 3, etc.) is temporarily secured to an anatomical structure (e.g., the interior of the heart, etc.) at an implant location (e.g., at or near the right ventricular apex, etc.). The implanted device 600 includes an EM emitter 610 (e.g., as one example of an EM emitter 310, etc.) that generates a position-dependent EM field that is detected by an EM tracker of a delivery system capsule 605 (e.g., an example of an instrument 130 of FIG. 1, etc.). The EM tracker 620 of the delivery system capsule 605 detects the position-dependent EM field generated by the EM emitter 610 of the implanted device 600 and, based on the detected position-dependent EM field, the locations (e.g., including orientations) of the implanted device 600 and the delivery system 605 are determined (e.g., by the computing device 100 of FIG. 1, system 200 of FIG. 2, etc.). The location of the implanted device 600 (as determined via the EM tracker 620 based on the EM field generated by the EM emitter 610) relative to the implanted device 600 is useable to aid in deployment accuracy of the prosthetic valve. Various examples display visual aids to a user based on the relative positions of the implanted device 600 and the delivery system capsule 605. In various examples, a cone 625 is defined (e.g., coaxial with the axis of the implanted device 600 and / or with a line from the implanted device 600 to a center of the tricuspid valve) and / or displayed to a user to aid in aligning the delivery system capsule 605 coaxially with the implanted device 600 and / or tricuspid valve. Additionally, in various examples leaflet commissure points of the tricuspid valve (e.g., and / or a perpendicular distance of the leaflet commissure points from the tracked position of the implanted device 600, etc.) areAttorney Docket No. A0012175W001 identified and / or displayed to a user to aid in navigating the delivery system capsule 605 with respect to the native anatomy of the specific patient of the procedure.

[0060] Referring to FIGS. 7A and 7B, illustrated are images showing an example implanted device 700 (e.g., as an example of the implantable device 300 of FIG. 3) including an US probe 730 (e.g., as an example of the US probe 330, etc.) and secured at an implant location at or near a right ventricular apex, such as for a TTVR procedure. FIGS. 7A and 7B show an example that can improve the effectiveness of tricuspid replacement therapy by providing US imaging data from a different location than from conventional US imaging, such as TEE, which has shadowing during the TTVR procedure.

[0061] FIGS. 7A and 7B show an additional use case of a TTVR procedure where examples provide navigation assistance data from an implanted US probe 730. The US probe 730 includes a wireless miniaturized US transducer. An implanted device 700 (e.g., as one example of implantable device 300 of FIG. 3, etc.) is temporarily secured to an anatomical structure (e.g., the interior of the heart, etc.) at an implant location (e.g., at or near the right ventricular apex, etc.). The implanted device 700 includes the US probe 730 (e.g., a phased array for multiplanar imaging, etc.). The US probe 730 implanted at or near the right ventricular apex provides unobstructed US imaging data to allow a user to identify the delivery system location for accurate deployment of the prosthesis. The implant position of the implanted device 730 can be located during prescreening based on pre-procedural imaging (e.g., US, CT, etc.). US imaging data is provided to a US workstation (e.g., US workstation 150 of FIG. 1, etc.) and / or computing device (e.g., computing device 100 of FIG. 1, system 200 of FIG. 2, etc.) from a US probe (e.g., of US imager 140 of FIG. 1, such as a TEE probe, etc.). A user interface of the US workstation and / or computing device allows a user to add markers to the US imaging, such as markers in the native leaflet plane and / or commissural points to aid in alignment of the implanted device 700 relative to the tricuspid valve. A user can verify whether and to what extent the implanted device 700 is coaxial with the tricuspid valve via live imaging.Additionally, various examples of the implanted device 700 include an EM emitter 710 or an EM tracker 720 useable in conjunction with an EM tracker 720 of a delivery system capsule 705 and / or an external EM emitter (not shown in FIG. 7, but which can be similar to EM emitter 510 of FIG. 5, etc.). Various examples of the implanted device 700 thatAtorney Docket No. A0012175W001 include an EM emiter 710 or an EM tracker 720 display visual aids to a user based on the relative positions of the implanted device 700 and the delivery system capsule 705. In various such examples, a cone 725 is defined (e.g., coaxial with the axis of the implanted device 700 and / or with a line from the implanted device 700 to a center of the tricuspid valve) and / or displayed to a user to aid in aligning the delivery system capsule 705 coaxially with the implanted device 700 and / or tricuspid valve. Additionally, in various examples leaflet commissure points of the tricuspid valve (e.g., and / or a perpendicular distance of the leaflet commissure points from the tracked position of the implanted device 700, etc.) are identified and / or displayed to a user to aid in navigating the delivery system capsule 705 with respect to the native anatomy of the specific patient of the procedure.

[0062] Referring to FIG. 8, illustrated is an image showing an example implanted device 800 (e.g., as an example of the implantable device 300 of FIG. 3) secured at an implant location at or near the lower end of the superior vena cava (SVC), such as for a TTVR procedure. The implantable device 800 is secured by an expandable stent anchor 880 (e.g., as one example of the anchor 380 of FIG. 3) tethered to a delivery catheter 805. In various examples, the implanted device 800 includes an EM emiter (e.g., EM emiter 310 of FIG. 3), an EM tracker (e.g., EM tracker 340 of FIG. 3), and / or an US probe (e.g., US probe 330 of FIG. 3). FIG. 8 shows an example that can improve the effectiveness of tricuspid replacement therapy by providing US imaging data from a different location than from conventional US imaging and / or an alternate imaging modality from conventional imaging modalities, such as TEE, which has shadowing during the TTVR procedure.

[0063] FIG. 8 shows an additional use case of a TTVR procedure where examples provide navigation assistance data from an implanted device that includes navigation assistance data from a US probe (e.g., with a wireless miniaturized US transducer) and / or an alternate imaging modality based on EM tracking. Delivery of the implanted device 800 to the implant location includes connecting the implanted device 800 to a frame of the self-expanding stent 880, which is crimped around the implanted device 800, and both are packaged within the delivery catheter 805. The delivery catheter 805 is navigated to deliver the implanted device 800 to the implant location. At the implant location, the frame of the self-expanding stent 880 expands and radially secures the implanted device 800 to the implant location in the SVC while allowing blood passage through the SVC during the procedure (e.g., the TTVR procedure, etc.). The stent 880 remains tethered toAttorney Docket No. A0012175W001 the delivery catheter 805 until the stent 880 and the implanted device 800 are recaptured by the delivery catheter 805 for removal.

[0064] In view of the foregoing structural and functional features described above, example methods will be better appreciated with reference to FIG. 9. While, for purposes of simplicity of explanation, the example method of FIG. 9 is shown and described as executing serially, it is to be understood and appreciated that the present examples are not limited by the illustrated order, as some actions could in other examples occur in different orders, multiple times and / or concurrently from that shown and described herein.Moreover, it is not necessary that all described actions be performed to implement a method.

[0065] FIG. 9 illustrates a flowchart of an example method 900 of providing navigation assistance data in connection with a procedure (e.g., a transcatheter procedure, etc.) at a target location (e.g., a heart valve, etc.) within a region of interest. In other examples, the blocks of example method 900 are a set of machine-readable instructions on a non-transitory machine-readable medium or are a set of operations performed by a processor executing machine-readable instructions as the operations.

[0066] At block 910, the method 900 includes securing (e.g., via an anchor 380, etc.) an implantable device (e.g., the implantable device 300, etc.) to a structure (e.g., an anatomical structure such as the apex of a ventricle or the lower end of the SVC, etc.) in the region of interest.

[0067] At block 920, the method 900 includes receiving the navigation assistance data via at least one of a first signal from the device or a second signal from an instrument (e.g., the instrument 130 of FIG. 1, such as a transcatheter delivery system, etc.). In some examples, the first signal includes US imaging data (e.g., from a US probe 330, etc.) and optionally EM tracking data (e.g., from an EM tracker 320, etc.) and the second signal is one of omitted (e.g., examples using only US imaging data as navigation assistance data, etc.) or includes EM tracking data (e.g., from an EM tracker of the instrument, etc.). In other examples, the first signal includes EM tracking data and the second signal includes EM tracking data (e.g., in examples that employ an external EM emitter for EM tracking of the implanted device and instrument, etc.). In additional examples, the first signal is omitted (or includes only sensor, etc. data without navigation assistance data, etc.) and theAttorney Docket No. A0012175W001 second signal includes EM tracking data (e.g., in examples that include an EM emitter in the implanted device for EM tracking, etc.).

[0068] At block 930, the method 900 includes determining a relative position between the device and the instrument based on the navigation data. In various examples, this relative position (e.g., which includes relative orientation in various examples, etc.) is determined by a computing device (e.g., the computing device 100 of FIG. 1, system 200 of FIG. 2, etc.) and / or output via a display visually (e.g., visually indicating the relative positions overlaid on imaging data, visually indicating the relative positions as US imaging data showing the instrument as imaged by a US probe of the implanted device, as numerical / text indication(s) of the relative positions, etc.).

[0069] At block 940, the method 900 includes navigating the instrument to the target location based at least in part on the determined relative position.

[0070] At block 950, the method 900 includes performing the procedure at the target location (e.g., deploying a valve prosthesis at a tricuspid valve for a TTVR procedure, etc.).

[0071] At block 960, the method 900 includes acquiring sensor data (e.g., pressure sensor data such as intracardiac pressure, cardiac signal data, etc.) from the implant location and / or applying a periodic electric signal (e.g., temporary cardiac pacing, etc.) to the implant location. In some examples, sensor data is included with navigation assistance data in the first signal. In the same or other examples, sensor data is acquired before and / or after the procedure for patient monitoring.

[0072] At block 970, the method 900 includes removing the implanted device from the structure, such as via a delivery transcatheter removing the implanted device via interaction with a tether (e.g., the tether 390, etc.) on the implanted device.

[0073] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of thisAttorney Docket No. A0012175W001 disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0074] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0075] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0076] The following additional examples are provided in connection with various aspects.

[0077] Example 1. A navigation system for a procedure associated with a target location within a region of interest, the navigation system comprising: an implantable device configured to be removably implanted at an implant location within the region of interest, wherein the implant location has a known position relative to the target location, and wherein the implantable device comprises: an anchor configured to secure the implantable device to a structure at the implant location; and one of an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field or an EM emitter configured to generate the EM field; an instrument comprising an additional EM tracker configured to detect the position-dependent property of the EM field; and a processing unit configured to: determine a relative position between the instrument and the implantable device based on the detected position-dependent property of the EM field; and output an indication of the relative position between the instrument and the implantable device.Attorney Docket No. A0012175W001

[0078] Example 2. The navigation system of example 1, wherein the implantable device comprises the EM tracker, and the navigation system further comprises another EM emitter configured to generate the EM field.

[0079] Example 3. The navigation system of any of examples 1-2, wherein the implantable device further comprises: a pressure sensor configured to determine a pressure associated with the implant location; and a transmitter configured to transmit data, wherein the data indicates the pressure associated with the implant location.

[0080] Example 4. The navigation system of any of examples 1-3, wherein the implantable device further comprises a set of electrodes configured to apply a periodic electrical signal to the structure.

[0081] Example 5. The navigation system of any of examples 1-4, wherein the implantable device further comprises: an electrical sensor configured to detect a periodic electric signal in the structure; and a transmitter configured to transmit data, wherein the data indicates a property of the periodic electrical signal.

[0082] Example 6. The navigation system of any of examples 1-5, wherein the anchor comprises a set of tines.

[0083] Example 7. The navigation system of any of examples 1-6, wherein the anchor comprises an expandable stent.

[0084] Example 8. The navigation system of any of examples 1-7, wherein the implantable device further comprises an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest, wherein the portion of the region of interest comprises the target location, and wherein the processing unit is further configured to receive the US imaging data and output an US image based on the US imaging data.

[0085] Example 9. The navigation system of any of examples 1-8, wherein the implantable device further comprises a tether configured to couple with an additional instrument to facilitate removal of the implantable device from the structure.

[0086] Example 10. A navigation system for a procedure associated with a target location within a region of interest, the navigation system comprising: an instrument; an implantable device configured to be removably implanted at an implant location within the region of interest, wherein the implant location has a known position relative to the target location, and wherein the implantable device comprises: an anchor configured to secureAttorney Docket No. A0012175W001 the implantable device to a structure at the implant location; and an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest, wherein the portion of the region of interest comprises the target location; a processing unit configured to: receive the US imaging data; and output an US image based on the US imaging data.

[0087] Example 11. The navigation system of example 10, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0088] Example 12. The navigation system of any of examples 10-11, wherein the instrument comprises an electromagnetic (EM) tracker configured to detect a positiondependent property of an EM field, and wherein the processing unit is further configured to: determine a position of the instrument based on the detected position-dependent property; and output an indication of the position of the instrument.

[0089] Example 13. The navigation system of example 12, wherein the implantable device further comprises an additional EM tracker configured to detect the position-dependent property of the EM field, and wherein the position of the instrument is a relative position between the instrument and the implantable device.

[0090] Example 14. The navigation system of any of examples 10-13, wherein the implantable device further comprises: a pressure sensor configured to determine a pressure associated with the implant location; and a transmitter configured to transmit data, wherein the data indicates the pressure associated with the implant location.

[0091] Example 15. The navigation system of any of examples 10-14, wherein the implantable device further comprises a set of electrodes configured to apply a periodic electrical signal to the structure.

[0092] Example 16. The navigation system of any of examples 10-15, wherein the implantable device further comprises: an electrical sensor configured to detect a periodic electric signal in the structure; and a transmitter configured to transmit data, wherein the data indicates a property of the periodic electrical signal.

[0093] Example 17. The navigation system of any of examples 10-16, wherein the anchor comprises a set of tines.

[0094] Example 18. The navigation system of any of examples 10-17, wherein the anchor comprises an expandable stent.Attorney Docket No. A0012175W001

[0095] Example 19. The navigation system of any of examples 10-18, wherein the implantable device further comprises a tether configured to couple with an additional instrument to facilitate removal of the implantable device from the structure.

[0096] Example 20. A device configured to be implanted within a region of interest, the device comprising: an anchor configured to removably secure the device to a structure within the region of interest at a location within the region of interest; an electromagnetic (EM) emitter configured to generate an EM field with a positiondependent property across the region of interest; a transmitter configured to transmit data; and an internal power source configured to provide power to the device.

[0097] Example 21. The device of example 20, further comprising a pressure sensor configured to determine a pressure associated with the location, wherein the data indicates the pressure.

[0098] Example 22. The device of example 21, wherein the data associated with the device comprises an alert in response to the pressure being greater than a first threshold or in response to the pressure being less than a second threshold.

[0099] Example 23. The device of any of examples 20-22, further comprising an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest, wherein the data comprises the US imaging data.

[0100] Example 24. The device of example 23, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0101] Example 25. The device of any of examples 20-24, further comprising a set of electrodes configured to apply a periodic electrical signal to the structure.

[0102] Example 26. The device of any of examples 20-25, further comprising an electrical sensor configured to detect a periodic electric signal in the structure, wherein the data indicates a property of the periodic electrical signal.

[0103] Example 27. The device of any of examples 20-26, wherein the anchor comprises a set of tines.

[0104] Example 28. The device of any of examples 20-27, wherein the anchor comprises an expandable stent.

[0105] Example 29. The device of any of examples 20-28, further comprising a tether configured to couple with an instrument to facilitate removal of the device from the structure.Attorney Docket No. A0012175W001

[0106] Example 30. A device configured to be implanted within a region of interest, the device comprising: an anchor configured to removably secure the device to a structure within the region of interest at a location within the region of interest; an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field; a transmitter configured to transmit data, wherein the data indicates the detected position-dependent property of the EM field; and an internal power source configured to provide power to the device.

[0107] Example 31. The device of example 30, further comprising a pressure sensor configured to determine a pressure associated with the location, wherein the data indicates the pressure.

[0108] Example 32. The device of example 31, wherein the data associated with the device comprises an alert in response to the pressure being greater than a first threshold or in response to the pressure being less than a second threshold.

[0109] Example 33. The device of any of examples 30-32, further comprising an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest, wherein the data comprises the US imaging data.

[0110] Example 34. The device of example 33, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0111] Example 35. The device of any of examples 30-34, further comprising a set of electrodes configured to apply a periodic electrical signal to the structure.

[0112] Example 36. The device of any of examples 30-35, further comprising an electrical sensor configured to detect a periodic electric signal in the structure, wherein the data indicates a property of the periodic electrical signal.

[0113] Example 37. The device of any of examples 30-36, wherein the anchor comprises a set of tines.

[0114] Example 38. The device of any of examples 30-37, wherein the anchor comprises an expandable stent.

[0115] Example 39. The device of any of examples 30-38, further comprising a tether configured to couple with an instrument to facilitate removal of the device from the structure.

[0116] Example 40. A method of providing navigation assistance data in connection with a procedure at a target location within a region of interest, comprising:Attorney Docket No. A0012175W001 securing a device to a structure at an implant location in the region of interest; receiving the navigation assistance data via at least one of a first signal from the device or a second signal received from an instrument; determining a relative position between the device and the instrument based on the navigation assistance data; navigating the instrument to the target location based at least in part on the determined relative position; performing the procedure at the target location; and removing the device from the structure.

[0117] Example 41. The method of example 40, wherein determining the location is based on the first signal, and the first signal is generated based on a positiondependent electromagnetic (EM) field detected at the device.

[0118] Example 42. The method of any of examples 40-41, wherein determining the location is based on the second signal, and the second signal is generated based on a position-dependent electromagnetic (EM) field detected at the instrument.

[0119] Example 43. The method of example 42, wherein the EM field is generated by the device.

[0120] Example 44. The method of any of examples 40-43, further comprising monitoring a pressure in the region of interest via the device.

[0121] Example 45. The method of any of examples 40-44, further comprising monitoring a periodic electric signal in the structure via the device.

[0122] Example 46. The method of any of examples 40-45, further comprising applying a periodic electric signal to the structure via the device.

[0123] Example 47. The method of any of examples 40-46, wherein the first signal comprises ultrasound (US) imaging data associated with a portion of the region of interest, wherein the portion of the region of interest comprises the target location, and wherein the navigating is based at least in part on the US imaging data.

[0124] Example 48. A navigation system for an intracardiac transcatheter procedure associated with a heart valve within a region of interest, the navigation system comprising: an implantable device configured to be removably implanted at an implant location within the region of interest, wherein the implant location has a known position relative to the heart valve, and wherein the implantable device comprises: an anchor configured to secure the implantable device to an anatomical structure at the implant location; and one of an electromagnetic (EM) tracker configured to detect a positiondependent property of an EM field or an EM emitter configured to generate the EM field;Attorney Docket No. A0012175W001 a transcatheter instrument comprising an additional EM tracker configured to detect the position-dependent property of the EM field; and a processing unit configured to: determine a relative position between the transcatheter instrument and the implantable device based on the detected position-dependent property of the EM field; and output an indication of the relative position between the transcatheter instrument and the implantable device.

[0125] Example 49. The navigation system of example 48, wherein the implantable device comprises the EM tracker, and the navigation system further comprises another EM emitter configured to generate the EM field.

[0126] Example 50. The navigation system of any of examples 48-49, wherein the implantable device further comprises: a pressure sensor configured to determine an intracardiac pressure associated with the implant location; and a transmitter configured to transmit data, wherein the data indicates the intracardiac pressure associated with the implant location.

[0127] Example 51. The navigation system of any of examples 48-50, wherein the implant location is within a ventricle of a heart, and wherein the implantable device further comprises a set of electrodes configured to apply temporary cardiac pacing to the heart.

[0128] Example 52. The navigation system of any of examples 48-51, wherein the implant location is within a ventricle of a heart, and wherein the implantable device further comprises: an electrical sensor configured to detect a cardiac signal in the anatomical structure; and a transmitter configured to transmit data, wherein the data indicates a property of the cardiac signal.

[0129] Example 53. The navigation system of any of examples 48-52, wherein the anchor comprises a set of tines.

[0130] Example 54. The navigation system of any of examples 48-53, wherein the anchor comprises an expandable stent, and wherein the implant location is within a portion of vasculature near the heart valve.

[0131] Example 55. The navigation system of any of examples 48-54, wherein the implantable device further comprises an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest, wherein the portion of the region of interest comprises the heart valve, and wherein the processing unit is furtherAttorney Docket No. A0012175W001 configured to receive the US imaging data and output an US image based on the US imaging data.

[0132] Example 56. The navigation system of any of examples 48-55, wherein the implantable device further comprises a tether configured to couple with an additional instrument to facilitate removal of the implantable device from the anatomical.

[0133] Example 57. A navigation system for an intracardiac transcatheter associated with a heart valve within a region of interest, the navigation system comprising: an instrument; an implantable device configured to be removably implanted at an implant location within the region of interest, wherein the implant location has a known position relative to the heart valve, and wherein the implantable device comprises: an anchor configured to secure the implantable device to an anatomical structure at the implant location; and an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest, wherein the portion of the region of interest comprises the heart valve; a processing unit configured to: receive the US imaging data; and output an US image based on the US imaging data.

[0134] Example 58. The navigation system of example 57, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0135] Example 59. The navigation system of any of examples 57-58, wherein the instrument comprises an electromagnetic (EM) tracker configured to detect a positiondependent property of an EM field, and wherein the processing unit is further configured to: determine a position of the instrument based on the detected position-dependent property; and output an indication of the position of the instrument.

[0136] Example 60. The navigation system of example 59, wherein the implantable device further comprises an additional EM tracker configured to detect the position-dependent property of the EM field, and wherein the position of the instrument is a relative position between the instrument and the implantable device.

[0137] Example 61. The navigation system of any of examples 57-60, wherein the implantable device further comprises: a pressure sensor configured to determine an intracardiac pressure associated with the implant location; and a transmitter configured to transmit data, wherein the data indicates the intracardiac pressure associated with the implant location.Attorney Docket No. A0012175W001

[0138] Example 62. The navigation system of any of examples 57-61, wherein the implant location is within a ventricle of a heart, and wherein the implantable device further comprises a set of electrodes configured to apply temporary cardiac pacing to the heart.

[0139] Example 63. The navigation system of any of examples 57-62, wherein the implantable device further comprises: an electrical sensor configured to detect a cardiac signal in the anatomical structure; and a transmitter configured to transmit data, wherein the data indicates a property of the cardiac signal.

[0140] Example 64. The navigation system of any of examples 57-63, wherein the anchor comprises a set of tines.

[0141] Example 65. The navigation system of any of examples 57-64, wherein the anchor comprises an expandable stent, and wherein the implant location is within a portion of vasculature near the heart valve.

[0142] Example 66. The navigation system of any of examples 57-65, wherein the implantable device further comprises a tether configured to couple with an additional instrument to facilitate removal of the implantable device from the anatomical.

[0143] Example 67. A device configured to be implanted within a region of interest of an intracardiac transcatheter procedure, the device comprising: an anchor configured to removably secure the device to an anatomical structure within the region of interest at a location within the region of interest; an electromagnetic (EM) emitter configured to generate an EM field with a position-dependent property across the region of interest; a transmitter configured to transmit data; and an internal power source configured to provide power to the device.

[0144] Example 68. The device of example 67, further comprising a pressure sensor configured to determine an intracardiac pressure associated with the location, wherein the data indicates the intracardiac pressure.

[0145] Example 69. The device of example 68, wherein the data associated with the device comprises an alert in response to the intracardiac pressure being greater than a first threshold or in response to the intracardiac pressure being less than a second threshold.

[0146] Example 70. The device of any of examples 67-69, further comprising an ultrasound (US) probe configured to generate US imaging data associated with a portionAttorney Docket No. A0012175W001 of the region of interest comprising a target location of the intracardiac transcatheter procedure, wherein the data comprises the US imaging data.

[0147] Example 71. The device of example 70, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0148] Example 72. The device of any of examples 67-71, wherein the location is within a ventricle of the heart, and wherein the device further comprises a set of electrodes configured to apply temporary cardiac pacing to the heart.

[0149] Example 73. The device of any of examples 67-72, further comprising an electrical sensor configured to detect a cardiac signal in the anatomical structure, wherein the data indicates a property of the cardiac signal.

[0150] Example 74. The device of any of examples 67-73, wherein the anchor comprises a set of tines.

[0151] Example 75. The device of any of examples 67-74, wherein the anchor comprises an expandable stent, and wherein the implant location is within a portion of vasculature near the heart valve.

[0152] Example 76. The device of any of examples 67-75, further comprising a tether configured to couple with an instrument to facilitate removal of the device from the anatomical structure.

[0153] Example 77. A device configured to be implanted within a region of interest of an intracardiac transcatheter procedure, the device comprising: an anchor configured to removably secure the device to an anatomical structure within the region of interest at a location within the region of interest; an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field; a transmitter configured to transmit data, wherein the data indicates the detected position-dependent property of the EM field; and an internal power source configured to provide power to the device.

[0154] Example 78. The device of example 77, further comprising a pressure sensor configured to determine an intracardiac pressure associated with the location, wherein the data indicates the intracardiac pressure.

[0155] Example 79. The device of example 78, wherein the data associated with the device comprises an alert in response to the intracardiac pressure being greater than aAttorney Docket No. A0012175W001 first threshold or in response to the intracardiac pressure being less than a second threshold.

[0156] Example 80. The device of any of examples 77-79, further comprising an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest comprising a target location of the intracardiac transcatheter procedure, wherein the data comprises the US imaging data.

[0157] Example 81. The device of example 80, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0158] Example 82. The device of any of examples 77-81, wherein the location is within a ventricle of the heart, and wherein the device further comprises a set of electrodes configured to apply temporary cardiac pacing to the heart.

[0159] Example 83. The device of any of examples 77-82, further comprising an electrical sensor configured to detect a cardiac signal in the anatomical structure, wherein the data indicates a property of the cardiac signal.

[0160] Example 84. The device of any of examples 77-83, wherein the anchor comprises a set of tines.

[0161] Example 85. The device of any of examples 77-84, wherein the anchor comprises an expandable stent, and wherein the implant location is within a portion of vasculature near the heart valve.

[0162] Example 86. The device of any of examples 77-85, further comprising a tether configured to couple with an instrument to facilitate removal of the device from the anatomical structure.

[0163] Example 87. A method of providing navigation assistance data in connection with an intracardiac transcatheter procedure at a heart valve within a region of interest, comprising: securing a device to an anatomical structure at an implant location in the region of interest; receiving the navigation assistance data via at least one of a first signal from the device or a second signal received from a transcatheter instrument; determining a relative position between the device and the transcatheter instrument based on the navigation assistance data; navigating the transcatheter instrument to the heart valve based at least in part on the determined relative position; performing the intracardiac transcatheter procedure at the heart valve; and removing the device from the anatomical structure.Attorney Docket No. A0012175W001

[0164] Example 88. The method of example 87, wherein determining the location is based on the first signal, and the first signal is generated based on a positiondependent electromagnetic (EM) field detected at the device.

[0165] Example 89. The method of any of examples 87-88, wherein determining the location is based on the second signal, and the second signal is generated based on a position-dependent electromagnetic (EM) field detected at the instrument.

[0166] Example 90. The method of example 89, wherein the EM field is generated by the device.

[0167] Example 91. The method of any of examples 87-90, further comprising monitoring an intracardiac pressure in the region of interest via the device.

[0168] Example 92. The method of any of examples 87-91, further comprising monitoring a cardiac signal in the anatomical structure via the device.

[0169] Example 93. The method of any of examples 87-92, wherein the anatomical structure is a ventricle of a heart, and wherein the method further comprises applying temporary cardiac pacing to the heart via the device.

[0170] Example 94. The method of any of examples 87-93, wherein the first signal comprises ultrasound (US) imaging data associated with a portion of the region of interest, wherein the portion of the region of interest comprises the heart valve, and wherein the navigating is based at least in part on the US imaging data.

[0171] Example 91. A device configured to be implanted within a region of interest, the device comprising: an anchor configured to removably secure the device to a structure within the region of interest at a location within the region of interest; an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest; a transmitter configured to transmit data, wherein the data comprises the US imaging data; and an internal power source configured to provide power to the device.

[0172] Example 92. The device of example 91, further comprising a pressure sensor configured to determine a pressure associated with the location, wherein the data indicates the pressure.

[0173] Example 93. The device of example 92, wherein the data associated with the device comprises an alert in response to the pressure being greater than a first threshold or in response to the pressure being less than a second threshold.Attorney Docket No. A0012175W001

[0174] Example 94. The device of any of examples 91-93, further comprising an electromagnetic (EM) emitter configured to generate an EM field with a positiondependent property across the region of interest.

[0175] Example 95. The device of any of examples 91-94, further comprising an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field, wherein the data indicates the position-dependent property of the EM field.

[0176] Example 96. The device of any of examples 91-95, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0177] Example 97. The device of any of examples 91-96, further comprising a set of electrodes configured to apply a periodic electrical signal to the structure.

[0178] Example 98. The device of any of examples 91-97, further comprising an electrical sensor configured to detect a periodic electric signal in the structure, wherein the data indicates a property of the periodic electrical signal.

[0179] Example 99. The device of any of examples 91-98, wherein the anchor comprises a set of tines.

[0180] Example 100. The device of any of examples 91-99, wherein the anchor comprises an expandable stent.

[0181] Example 101. The device of any of examples 91-100, further comprising a tether configured to couple with an instrument to facilitate removal of the device from the structure.

[0182] Example 102. A device configured to be implanted within a region of interest of an intracardiac transcatheter procedure, the device comprising: an anchor configured to removably secure the device to an anatomical structure within the region of interest at a location within the region of interest; an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest; a transmitter configured to transmit data, wherein the data comprises the US imaging data; and an internal power source configured to provide power to the device.

[0183] Example 103. The device of example 102, further comprising a pressure sensor configured to determine an intracardiac pressure associated with the location, wherein the data indicates the intracardiac pressure.Attorney Docket No. A0012175W001

[0184] Example 104. The device of example 103, wherein the data associated with the device comprises an alert in response to the intracardiac pressure being greater than a first threshold or in response to the intracardiac pressure being less than a second threshold.

[0185] Example 105. The device of any of examples 102-104, further comprising an electromagnetic (EM) emitter configured to generate an EM field with a positiondependent property across the region of interest.

[0186] Example 106. The device of any of examples 102-105, further comprising an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field, wherein the data indicates the position-dependent property of the EM field.

[0187] Example 107. The device of any of examples 102-106, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

[0188] Example 108. The device of any of examples 102-107, wherein the location is within a ventricle of the heart, and wherein the device further comprises a set of electrodes configured to apply temporary cardiac pacing to the heart.

[0189] Example 109. The device of any of examples 102-108, further comprising an electrical sensor configured to detect a cardiac signal in the anatomical structure, wherein the data indicates a property of the cardiac signal.

[0190] Example 110. The device of any of examples 102-109, wherein the anchor comprises a set of tines.

[0191] Example 111. The device of any of examples 102-110, wherein the anchor comprises an expandable stent, and wherein the implant location is within a portion of vasculature near the heart valve.

[0192] Example 112. The device of any of examples 102-111, further comprising a tether configured to couple with an instrument to facilitate removal of the device from the anatomical structure.

Claims

Attorney Docket No. A0012175W001WHAT IS CLAIMED IS:

1. A navigation system for a procedure associated with a target location within a region of interest, the navigation system comprising: an implantable device configured to be removably implanted at an implant location within the region of interest, wherein the implant location has a known position relative to the target location, and wherein the implantable device comprises: an anchor configured to secure the implantable device to a structure at the implant location; and one of an electromagnetic (EM) tracker configured to detect a position-dependent property of an EM field or an EM emitter configured to generate the EM field; an instrument comprising an additional EM tracker configured to detect the positiondependent property of the EM field; and a processing unit configured to: determine a relative position between the instrument and the implantable device based on the detected position-dependent property of the EM field; and output an indication of the relative position between the instrument and the implantable device.

2. The navigation system of claim 1, wherein the implantable device comprises the EM tracker, and the navigation system further comprises another EM emitter configured to generate the EM field.

3. The navigation system of any of claims 1-2, wherein the implantable device further comprises: a pressure sensor configured to determine a pressure associated with the implant location; and a transmitter configured to transmit data, wherein the data indicates the pressure associated with the implant location.Attorney Docket No. A0012175W0014. The navigation system of any of claims 1-3, wherein the implantable device further comprises a set of electrodes configured to apply a periodic electrical signal to the structure.

5. The navigation system of any of claims 1-4, wherein the implantable device further comprises: an electrical sensor configured to detect a periodic electric signal in the structure; and a transmitter configured to transmit data, wherein the data indicates a property of the periodic electrical signal.

6. The navigation system of any of claims 1-5, wherein the anchor comprises a set of tines.

7. The navigation system of any of claims 1-6, wherein the anchor comprises an expandable stent.

8. The navigation system of any of claims 1-7, wherein the implantable device further comprises an ultrasound (US) probe configured to generate US imaging data associated with a portion of the region of interest, wherein the portion of the region of interest comprises the target location, and wherein the processing unit is further configured to receive the US imaging data and output an US image based on the US imaging data.

9. The navigation system of claim 8, wherein the US probe comprises a phased array, and the US imaging data comprises multiplanar US imaging data.

10. The navigation system of any of claims 1-9, wherein the implantable device further comprises a tether configured to couple with an additional instrument to facilitate removal of the implantable device from the structure.

11. The navigation system of any of claims 1-10, wherein the anchor comprises an expandable stent, and wherein the implant location is within a portion of vasculature near a heart valve.Attorney Docket No. A0012175W00112. The navigation system of any of claims 1-10, wherein the implant location is within a ventricle of a heart, and wherein the implantable device further comprises a set of electrodes configured to apply temporary cardiac pacing to the heart.

13. The navigation system of any of claims 1-10, wherein the implantable device is an intracardiac transcatheter that is associated with a heart valve that is the target location within the region of interest.

14. The navigation system of any of claims 1-10, wherein the implantable device further comprises an internal power source configured to provide power to the implantable device.

15. The navigation system of any of claims 1-10, wherein the instrument and / or the implantable device is configured to provide a signal comprising navigation assistance data.

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